MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD BIOSYN; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	XX-5229J
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during suturing, the suture thread broke.Nothing fell into the cavity.The procedure was completed with another device.There was no injury caused to the patient and no medical intervention was required as a result of the device issue.

• Brand Name: BIOSYN
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6952073
• Report Number: 9612501-2017-06428
• Device Sequence Number: 1011110
• Product Code: GAM
• UDI-Device Identifier: 10884521113756
• UDI-Public: 10884521113756
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: XX-5229J
• Device Catalogue Number: XX-5229J
• Device Lot Number: D6B2266X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1